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Enzygnost HBsAg Confirmatory Test - SFDA Registration ME0000001481SFDAA00840

Access comprehensive regulatory information for Enzygnost HBsAg Confirmatory Test in the Saudi Arabia medical device market through Pure Global AI's free database. This Annex II List A device is registered with Saudi Arabia SFDA under registration number ME0000001481SFDAA00840 and manufactured by Siemens Healthcare diagnostics products Gmbh.

This page provides complete registration details including product category (Chemicals), manufacturer information, model details, and regulatory compliance data from the official Saudi Arabia SFDA medical device database. Pure Global AI offers free access to Saudi Arabia's complete medical device registry, helping global MedTech companies navigate SFDA regulations efficiently.

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SFDA Official Data
Annex II List A
ME0000001481SFDAA00840
Enzygnost HBsAg Confirmatory Test
SFDA Registration: ME0000001481SFDAA00840
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Product Information

for the detection of Hepatitis B

Product Use

Confirmatory test for the detection of Hepatitis B (surface) antigen in conjunction with Enzygnostยฎ HBsAg 5.0 in human serum or Enzygnostยฎ HBsAg 6.0 in human serum and plasma

Device Classification
Risk Class
Annex II List A
Product Category
Chemicals
Product Type
IVD
Registration Information
Registration ID
ME0000001481SFDAA00840
Authorization ID
GHTF-2016-2406
Status
Active
Expire Date
May 29, 2017
Model Information
Model ID(s)
OSFC13
Product Accessories

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